FDAFDA · Food and drugs·Recall number D-1214-2014
Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Published April 16, 2014 · Recall initiated: December 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zions RX Formulations Services LLC dba RX Formuations Serv.
- Distributor
- AZ
- Lot
- Lot #: 117037@3 Expiration Date: 12/13/2013 Lot #: 117899@1 Expiration Date: 01/03/2014 Lot #: 118289@7 Expiration Date: 01/09/2014 Lot #: 118078@56 Expiration Date: 01/03/2014 Lot #:118394@29 Expiration Date: 01/09/2014 Lot #: 118338@10 Expiration Date: 01/09/2014 Lot #: 118056@46 Expiration Date: 01/02/2014
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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